510(k) K780702
- Device
- CSS-60 DIGITAL HEART RATE METER
- Applicant
- BURDICK CORP.
- 510(k) number
- K780702
- Product code
- DRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-19
- Date received
- 1978-04-25
- Regulation
- 870.2300
- Classification name
- Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code DRT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-05-20 |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-02-03 |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 2026-01-28 |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025-07-29 |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024-05-30 |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | 2024-03-22 |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2024-02-09 |
| K223163 | Sleepiz One+ | Sleepiz AG | 2023-08-18 |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2022-09-28 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021-04-26 |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
| K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018-06-22 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | Ivy Biomedical Systems, Inc. | 2016-05-27 |
Legacy Summary#
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FDA Review#
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